On May 7, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the successful treatment of the first patient in Italy in its feasibility and safety study of intratumoral diffusing alpha-emitter radiation for locally advanced pancreatic cancer (Protocol CTP-PANC-03). The procedure was performed at the Azienda Ospedaliera Universitaria Integrata di Verona by a multidisciplinary team of the Pancreas Institute, led by Pr. Salvatore Paiella, MD, PhD, principal investigator of the trial and Associate Professor of General Surgery at the University of Verona.

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Pancreatic cancer remains one of the most lethal malignancies in Italy. The 2024 incidence is nearly evenly distributed between men (6,873 cases) and women (6,712 cases), with national five-year net survival of just 11% in men and 12% in women. Roughly one patient in five is diagnosed when the tumor is still localized and amenable to surgery, meaning approximately 80% present with already advanced disease. Pancreatic ductal adenocarcinoma is the fourth leading cause of cancer-related death in women and the sixth in men in Italy, and approximately 30% of patients present with locally advanced, inoperable disease – the population for whom this study was designed.

By enabling two complementary delivery pathways – endoscopic ultrasound (EUS) and percutaneous – within a single protocol, the study aims to bring interventional radiologists and interventional oncologists into the Alpha DaRT pancreatic treatment paradigm alongside gastroenterologists, endoscopists and surgeons, and to accommodate patients whose tumor location or anatomy is less amenable to EUS access alone.

Uzi Sofer, CEO of Alpha Tau, commented: "The Pancreas Institute in Verona is widely regarded as one of the leading pancreatic cancer centers in the world, and it has been a tremendous privilege to partner with Pr. Paiella and his brilliant team to offer the surgical, scientific, and multidisciplinary approach that this disease demands – a disease in which Italian patients face an exceptionally grim outlook. Just as significant is that this is the first Alpha DaRT protocol to incorporate the percutaneous delivery route. That choice reflects what we call our ‘Innovation in Simplicity’ philosophy at Alpha Tau: rather than asking physicians to learn fundamentally new techniques, our R&D team’s focus is on adapting Alpha DaRT to the workflows that interventional radiologists, interventional oncologists, gastroenterologists, and surgeons already perform every day. Each delivery route we open up means more alternatives for physicians, more capable centers, and ultimately more lives potentially reached."

Robert B. Den, MD, Chief Medical Officer of Alpha Tau, stated: "With this study, three complementary Alpha DaRT pancreatic cancer trials are advancing simultaneously, each designed for a distinct clinical context. Our IMPACT trial in the United States evaluates Alpha DaRT combined with chemotherapy in newly diagnosed unresectable patients, ACAPELLA in France evaluates Alpha DaRT with capecitabine in patients who have completed first-line mFOLFIRINOX, and this study is designed specifically for those who have already received chemotherapy or who are medically unfit for systemic treatment – a real-world population that often has no defined next step – and evaluates Alpha DaRT as a stand-alone local intervention. The protocol’s allowance of percutaneous source placement carries scientific weight beyond physician access: it gives us the opportunity to generate prospective safety, dosimetric, and clinical outcome data on an alternative delivery route that interventional teams already use routinely for pancreatic procedures. Doing this work with the team at the Verona Pancreas Institute, an internationally recognized reference center, gives us confidence in the rigor with which the evidence will be generated."

Pr. Salvatore Paiella, MD, PhD, principal investigator and Associate Professor of General Surgery at the Pancreas Institute, University of Verona, added: "At the Pancreas Institute of the University of Verona, our patients benefit from a genuinely multidisciplinary model in which surgeons, gastroenterologists, endoscopists, oncologists, radiologists, and pathologists operate as a single team, supported by one of the highest pancreatic surgical volumes in Europe and a long-established research program. That clinical foundation is what allows us to undertake a study of this kind with the diligence it requires. From a procedural standpoint, the Alpha DaRT insertion proved straightforward – the sources are placed directly into the tumor through image-guided approaches, in a single session, without the burden of repeated treatments. Being the first center anywhere to evaluate the percutaneous delivery route within an Alpha DaRT protocol is something we take particular pride in. It broadens the eligible patient population beyond cases optimally suited to endoscopic access, and positions us to help define how this therapy is integrated into the wider pancreatic cancer treatment pathway. I am glad to work with Dr. Stefano Francesco Crinò and Prof. Mirko D’Onofrio, who both have extensive experience in interventional procedures in pancreatic tumors."

About the Study

CTP-PANC-03 ("A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer") is a prospective, interventional, open-label, single-arm, single-center clinical study planned to enroll up to 15 patients with locally advanced pancreatic cancer at the Azienda Ospedaliera Universitaria Integrata di Verona, with a planned safety interim analysis after the first 5 patients. Eligible patients must have histologically or cytologically confirmed locally advanced pancreatic cancer, have received at least one line of chemotherapy or be medically unfit for chemotherapy, and have an unresectable tumor of ≤ 5 cm in longest diameter. The primary objective is to evaluate the feasibility and safety of Alpha DaRT source placement; secondary objectives include local control per RECIST v1.1, changes in CA 19-9 biomarker levels, tumor coverage, and adverse event incidence. Exploratory objectives include changes in immune biomarkers (CD3, CD4, CD8, CD69, CD137) following treatment. Per protocol, Alpha DaRT sources may be delivered using either endoscopic ultrasound guidance or a percutaneous approach.

(Press release, Alpha Tau Medical, MAY 7, 2026, View Source [SID1234665300])

On May 7, 2026 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported recent business progress and financial results for the first quarter 2026.

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"I am pleased to continue building on our progress made so far in 2026," stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "Receiving Fast Track Designation is confirmation that an unmet medical need exists in chronic HBV infection and pevifoscorvir sodium has the potential to be superior to current therapies based on clinical data to date, which was evaluated by the FDA when determining the granting of this designation. In addition, we completed the first interim analysis for the B-SUPREME HBeAg- cohort with a positive outcome reflecting that the study will continue, the futility criteria were not met, and study drugs were well tolerated. The recommendation from the DSMB to increase participants has the potential to increase the probability of success of the B-SUPREME study. It is important to note, that prior to the B-SUPREME study there has not been a randomized controlled study of treatment naïve chronic HBV infection participants using tenofovir disoproxil fumarate (TDF) as the active comparator to measure HBV DNA response with the most sensitive PCR assay currently available (LLOQ <10 IU/mL). Also, we are pleased to build on our existing relationship with Amoytop with the partnership of pevifoscorvir sodium in Greater China which can potentially accelerate approval in the region. Taken together, this progress demonstrates how our team has continued to execute on our goals. As we look forward to the back half of the year, I am excited for our continued developments as we progress pevifoscorvir sodium and our other drug candidates. In particular, I look forward to providing updates on our potentially best-in-class ASO for chronic HBV infection, which is moving nicely through IND-enabling studies."

Recent Business Progress

Pipeline Updates

Pevifoscorvir sodium: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection

Pevifoscorvir sodium was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for chronic hepatitis B virus (HBV) infection.
The Phase 2 B-SUPREME study (NCT06963710) is currently ongoing. As of April 2026, there were 74 participants enrolled in the HBeAg- cohort (Part 2a), with 103 participants enrolled in the HBeAg+ cohort (Part 1a).
The study design for the Phase 2 B-SUPREME study includes pre-specified sample size re-estimations for both Parts 1a and 2a to ensure sufficient power to demonstrate a statistically significant treatment effect at the primary endpoint. The first pre-specified interim analysis of the Phase 2 B-SUPREME study was performed after approximately 60% of HBeAg- participants (N=34, Part 2a) reached Week 12 or later. In addition, safety data was reviewed for all participants enrolled in the study (N=174) at the time the interim analysis was performed. Findings from the first interim analysis include:
The Drug Safety Monitoring Board (DSMB) recommended increasing the sample size of Part 2a from 74 currently enrolled to 100 participants. A futility analysis was performed; the prespecified futility criteria were not met, per the statistical analysis plan.
The study drugs were well-tolerated with no clinically concerning laboratory, physical examination, vital sign, or ECG abnormalities. No viral breakthrough related to study drugs has been observed in the study to date.
A second protocol defined interim analysis is planned when ~50% of HBeAg+ participants complete 24 weeks of the treatment period, with this enrollment threshold previously reached in January 2026. The second interim analysis is expected in the second half of 2026.
Topline data for both the HBeAg- and HBeAg+ cohorts are expected in 2027.
96-weeks of dosing have been completed in the Phase 1 study (NCT04536337) with long-term post-treatment data expected to be presented at the upcoming European Association for the Study of the Liver (EASL) 2026 Congress.
The Company entered into an exclusive license deal with Xiamen Amoytop Biotech Co., Ltd. (Amoytop) to develop and commercialize pevifoscorvir sodium in Greater China for chronic HBV infection. Along with a $25M USD upfront, Aligos is entitled to up to $420M USD in clinical, regulatory, and sales milestones with tiered, high single-digit royalties.

ALG-170675: Potential best-in-class antisense oligonucleotide (ASO) for chronic hepatitis B virus (HBV) infection

Along with our partner Amoytop, ALG-170675 has begun IND-enabling studies. Current costs for development in China are being funded by Amoytop, who maintain rights in Greater China.
This next-generation ASO works via two mechanisms of action. It targets and destroys HBsAg-encoding mRNA and activates the immune response through TLR-8 agonism.
ALG-055009: Potential best-in-class small molecule THR-β for obesity, MASH

Additional nonclinical data demonstrating the potential synergies of ALG-055009 and incretin receptor agonists are expected to be presented at upcoming scientific conferences.
Evaluation of a variety of options to fund continued development, including potential out-licensing, is ongoing.
Financial Results for the Three Months Ended March 31, 2026

Cash, cash equivalents and investments totaled $54.9 million as of March 31, 2026, compared with $77.8 million as of December 31, 2025. Our cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the fourth quarter of 2026, inclusive of the $25M upfront expected from the Amoytop Greater China License deal for pevifoscorvir sodium.

Net loss for the three months ended March 31, 2026 was $23.0 million or basic and diluted net loss per common share of $(2.21), compared to net income of $43.1 million or basic net income per common share of $5.12, and diluted net loss per common share of $(2.11) for the three months ended March 31, 2025.

Research and development (R&D) expenses for the three months ended March 31, 2026 were $23.4 million, compared with $14.5 million for the same period of 2025. The increase was primarily due to an increase in third-party expenses for the pevifoscorvir sodium Phase 2 clinical trial. Total R&D stock-based compensation expense incurred for the three months ended March 31, 2026 was $0.7 million, compared with $0.5 million for the same period of 2025.

General and administrative (G&A) expenses for the three months ended March 31, 2026 were $6.4 million, compared with $5.1 million for the same period of 2025. The decrease in G&A expenses for this comparative period is primarily due to a decrease in legal and other related expenses. Total G&A stock-based compensation expense incurred for the three months ended March 31, 2026 was $0.6 million, compared with $0.4 million for the same period of 2025.

Interest and other income, net, was income of $0.8 million for the three months ended March 31, 2026 compared with income of $0.9 million for the same period in 2025.

Change in fair value of 2023 common warrants for the three months ended March 31, 2026, was income of $3.4 million compared with income of $61.5 million for the same period of 2025.

(Press release, Aligos Therapeutics, MAY 7, 2026, View Source [SID1234665299])

On May 7, 2026 Alector, Inc. (Nasdaq: ALEC), a biotechnology company focused on developing therapies to counteract the devasting progression of neurodegeneration, reported first quarter 2026 financial results and recent portfolio and business updates. As of March 31, 2026, Alector’s cash, cash equivalents, and investments totaled $206.5 million.

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"Over the past seven years, we have built a highly differentiated blood-brain barrier platform with the versatility to deliver antibodies, enzymes, proteins, and siRNA to the brain," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "We have a rich and growing pipeline of ABC-enabled programs, and we remain deeply committed to developing therapies that can make a meaningful difference for patients living with neurodegenerative diseases."

Recent Program Updates

Alector Brain Carrier (ABC): Preclinical and Research Pipeline

At the core of Alector’s strategy is the Alector Brain Carrier (ABC), the company’s proprietary platform designed to enhance the delivery of therapeutics to the brain. ABC is intended for peripheral dosing and is adaptable across multiple drug modalities, including antibodies, enzymes, and siRNA.

The platform is built on core design principles of versatility, optimized binding properties, and translatability, with the goal of achieving efficient and targeted brain delivery while maintaining a favorable safety profile. Across multiple ABC-enabled programs, preclinical studies have demonstrated robust brain penetration, supporting the advancement of a broad pipeline aimed at addressing the underlying drivers of neurodegenerative diseases.

AL037/AL137

Alector continues to advance AL037/AL137, its ABC-enabled anti-amyloid beta (Aβ) antibody program for the treatment of AD, through investigational new drug (IND)-enabling studies. The company is targeting an IND submission in Q1 2027.
Both of our AL037 and AL137 candidates are engineered for optimal brain uptake, potency, safety, and convenience. Both candidates comprise the same high-affinity, fully human antibody that selectively binds PyroGlu3, a validated epitope on toxic amyloid beta found in plaques and retain an active effector function intended to facilitate myeloid-mediated plaque clearance. AL037 and AL137 each incorporates Alector’s proprietary ABC technology with TfR binding domains that bind the same epitope on TfR, but with different affinities and binding kinetics, to balance brain penetration and plaque removal with minimized hematologic adverse effects.
AL050

Alector continues to progress AL050, its ABC-enabled engineered glucocerebrosidase (GCase) enzyme replacement therapy (ERT) for PD, through preclinical development.
AL050 is designed to address key challenges associated with enzyme delivery to the brain, featuring an engineered GCase with improved activity and stability and a silenced effector function to maximize safety, paired with Alector’s tunable ABC technology. Preclinical studies to date have demonstrated increased GCase activity and reduced toxic substrate accumulation, supporting its continued preclinical development as a potential therapy for PD and Lewy body dementia (LBD) associated with GBA loss-of-function mutations and subsequently for idiopathic PD and LBD. We continue to evaluate our timeline to the clinic.
ABC siRNA Platform

Alector is advancing its ABC-enabled siRNA platform with the goal of making treatment more accessible by enabling peripheral dosing as a potential alternative to traditional intrathecal delivery.
Alector continues to advance AL064/AL164, its ABC-enabled tau siRNA program for the treatment of AD and other tauopathies. AL064 demonstrated robust tau mRNA knockdown and durable reduction of phospho-Tau 217 in non-human primate studies, and it was subsequently modified to further optimize siRNA stability. This modified form is advancing into IND-enabling studies as AL164.
In addition to AL164, the company is advancing early-stage siRNA programs toward lead candidate selection, including ADP062-ABC, an alpha-synuclein siRNA for PD and ADP065-ABC, an NLRP3 siRNA for multiple neurodegenerative conditions, reflecting the broad applicability of the ABC platform across disease mechanisms.
Progranulin Program (nivisnebart (AL101/GSK4527226)

The global, randomized, double-blind, placebo-controlled PROGRESS-AD Phase 2 clinical trial of nivisnebart (AL101/GSK4527226) in early AD has been discontinued following a pre-specified interim futility analysis. An independent data monitoring committee concluded that the trial was unlikely to meet its primary endpoint of slowing disease progression at completion. As the company’s platform and pipeline have continued to evolve, Alector remains focused on the significant opportunities ahead across its ABC-enabled programs.
First Quarter 2026 Financial Results

Revenue. Collaboration revenue for the quarter ended March 31, 2026, was $1.0 million, compared to $3.7 million for the same period in 2025. The decrease in year-over-year collaborative revenue was primarily due to lower manufacturing-related activity to support the Nivisnebart Phase 2 study in early Alzheimer’s disease.

R&D Expenses. Total research and development expenses for the quarter ended March 31, 2026, were $17.9 million, compared to $33.6 million for the quarter ended March 31, 2025. The decrease was mainly due to a decrease in personnel-related costs as a result of the reductions in force as well as a decrease in research and development expenses for the AL002 program.

G&A Expenses. Total general and administrative expenses for the quarter ended March 31, 2026, were $8.1 million, compared to $14.7 million for the quarter ended March 31, 2025. The decrease was mainly driven by a decrease in personnel-related costs as a result of the reductions in force.

Net Loss. For the quarter ended March 31, 2026, Alector reported a net loss of $22.9 million, or $0.21 per share, compared to a net loss of $40.5 million, or $0.41 net loss per share, for the same period in 2025.

Cash Position. Cash, cash equivalents, and investments were $206.5 million as of March 31, 2026. Management anticipates that this will be sufficient to fund Alector’s operations at least through 2027.

(Press release, Alector, MAY 7, 2026, View Source [SID1234665298])

On May 7, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the Final Primary Endpoint Report on Objective Response Rate data from a University of Pittsburgh Medical Center ("UPMC") Phase 2 clinical trial – in which AIM and Merck Sharp & Dohme ("Merck") are collaborators – evaluating Ampligen (rintatolimod) in combination with checkpoint inhibition and chemotherapy in recurrent ovarian cancer-data that may signal a major step forward in overcoming resistance to immunotherapy. The study aimed to improve clinical outcomes by overcoming the immunosuppressive tumor microenvironment characteristic of ovarian cancer through locoregional and systemic immune activation strategies. This clinical trial was financially supported by a Merck grant.

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Read more about the study at ClinicalTrials.gov: NCT03734692.

Topline results included:

50% Objective Response Rate (ORR), including 21% complete responses
79% Clinical Benefit Rate
Median Overall Survival of 32.5 months
Durable responses exceeding 70+ months in select patients
No Grade 4 or 5 toxicities observed
Read the full UPMC Primary Endpoint Report here.

Collection of additional secondary endpoint data including progression-free survival, time to disease progression and overall survival is expected to be completed in January 2027.

Robert P. Edwards, MD, McCall Chair of Obstetrics, Gynecology, and Reproductive Science at the University of Pittsburgh School of Medicine, stated: "This single-arm Phase 2 trial is the third in a series of consecutive studies evaluating IP chemotherapy or chemoimmunotherapy using this analytical approach. The addition of IP Ampligen and systemic PD-1 checkpoint inhibition to IP cisplatin chemotherapy resulted in a significant improvement in both clinical response rates and immune activation across highly comparable patient cohorts in the 3 trials."

AIM Chief Executive Officer Thomas K. Equels stated, "These results represent what we believe is a strong step forward in the potential to enhance treatment of recurrent ovarian cancer, if further studies support findings of relatively low toxicity, clinical benefit and durable response. Once again, data suggests that Ampligen may unlock the full potential of checkpoint immunotherapies. We are particularly encouraged by the durability of the observed responses. This supports our proposition that Ampligen has the potential to play a major role in solid tumor immuno-oncology – expanding the number of patients who benefit from checkpoint inhibitors across multiple cancer types, including ovarian cancer and pancreatic cancer. With strong intellectual property protection extending into 2039 and a growing body of positive clinical evidence, we believe we are well positioned to advance Ampligen into later-stage development and strategic partnerships."

(Press release, AIM ImmunoTech, MAY 7, 2026, View Source [SID1234665297])

On May 7, 2026 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported its first quarter 2026 results and provided a business update.

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"argenx continues to deliver meaningful impact for patients, reflected by our 17th consecutive quarter of VYVGART growth," said Karen Massey, Chief Executive Officer of argenx. "Looking ahead, VYVGART has the potential to become the first and only approved therapy across MG, pending FDA decisions on label expansions into seronegative and ocular populations. At the same time, we are extending our leadership in FcRn into rheumatology, beginning with the upcoming myositis readout. Our next pipeline candidate, empasiprubart, is progressing toward its first registrational readout in MMN, and we continue to advance a broad and differentiated pipeline. With these opportunities, we remain focused on delivering transformative outcomes for patients while creating sustained value for all stakeholders."

Vision 2030

argenx continues to advance its ‘Vision 2030’ anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications, and progress five pipeline candidates into Phase 3 development by 2030.

Expanding global VYVGART opportunity and shaping the long-term future of FcRn

VYVGART (IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc) is a first-and-only IgG Fc-antibody fragment that targets the neonatal Fc receptor (FcRn). It is approved in three indications, including generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan. argenx is driving broad adoption as the leading precision biologic in MG and CIDP while advancing multiple label expansions. argenx is also shaping the future of FcRn medicines by advancing new pipeline candidates and delivery modalities.

Generated $1.3 billion in global product net sales in the first quarter of 2026, representing an increase of approximately 63% or $0.5 billion in year-over-year growth
Prescription Drug User Fee Act (PDUFA) target action date for anti-acetylcholine receptor antibody negative (AChR-Ab-) gMG (MuSK+, LRP4+ and triple seronegative) is May 10, 2026
Positive topline results from ADAPT OCULUS were recently presented at AAN; these data support planned sBLA submission to expand VYVGART label into oMG
Topline results from ALKIVIA study (myositis) expected in third quarter of 2026
Topline results from ADVANCE-NEXT study (primary ITP) expected in first half of 2027
Registrational study in Graves’ disease (GD) expected to initiate in 2026, expanding development into thyroid-driven autoimmunity
Topline results from UNITY study (Sjogren’s disease) expected in second half of 2027
VYVGART SC autoinjector expected to launch in 2027 for all approved indications
Progressing two future FcRn molecules: ARGX-213 is Phase 3-ready and ARGX-124 is in Phase 1

Advancing empasiprubart

Empasiprubart is a first-in-class, humanized monoclonal antibody designed to inhibit complement factor C2, selectively blocking activation of the classical and lectin complement pathways. It is being evaluated in registrational studies in multifocal motor neuropathy (MMN) and CIDP, and in a combination study with VYVGART in gMG.

Topline results from EMPASSION study (MMN) expected in fourth quarter of 2026
Topline results from EMVIGORATE and EMNERGIZE studies (CIDP) expected in second half of 2027
Decision for Phase 2 VARVARA study (Delayed Graft Function) expected mid-year 2026 following completion of 52-week efficacy analysis
ADAPT-Forward combination study ongoing to evaluate empasiprubart as an add on therapy to efgartigimod in gMG
Delivering next wave of immunology innovation

By the end of 2026, the argenx pipeline is expected to include a total of ten molecules in clinical development. Beyond efgartigimod and empasiprubart, this includes adimanebart (a MuSK agonist); ARGX-121 (anti-IgA), ARGX-109 (anti-IL-6), and three additional molecules from the Immunology Innovation Program (IIP). Collectively, these programs support argenx’s goal of launching, on average, one new pipeline candidate per year.

Adimanebart CMS registrational study on track to start in third quarter of 2026
Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) expected to start in 2026
Three new first-in-class molecules on track to enter Phase 1 in 2026, including ARGX-118 (Galectin-10 inhibitor), ARGX-125 (bispecific antibody), and TSP-101, the Fn14-targeting program from the Tensegrity research collaboration

Key business highlights

On May 6, 2026, Karen Massey was appointed Chief Executive Officer and executive director of the argenx Board of Directors following the Annual General Meeting of Shareholders. Tim Van Hauwermeiren was appointed non-executive director and Chairperson of the Board of Directors
In March 2026, argenx expanded its global presence in Asia with the establishment of an argenx affiliate in China to broaden its access to novel biology and support early-stage research
FIRST QUARTER 2026 FINANCIAL RESULTS

argenx SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Three Months Ended
March 31,
(in millions of $ except for per share data) 2026 2025
Product net sales $ 1,298 $ 790
Other operating income* 15 17
Total operating income 1,313 807

Cost of sales $ (121) $ (81)
Research and development expenses* (443) (311)
Selling, general and administrative expenses (355) (276)
Total operating expenses (919) (668)

Operating profit $ 394 $ 139

Financial income $ 44 $ 37
Financial expense (1) (1)
Exchange (losses)/gains (11) 27

Profit for the period before taxes $ 426 $ 202
Income tax expense $ (60) $ (33)
Profit for the period $ 366 $ 169
Profit for the period attributable to:
Owners of the parent $ 366 $ 169
Weighted average number of shares outstanding 62,056,886 60,983,325
Basic profit per share (in $) $ 5.90 $ 2.78
Weighted average number of shares outstanding for diluted profit per share 66,356,591 65,664,300
Diluted profit per share (in $) $ 5.52 $ 2.58
*Comparative figures have been aligned with the presentation adopted in the current period, reflecting the combination of: collaboration revenue and other operating income, as well as the combination of research and development expenses and loss from investment in a joint venture.

DETAILS OF THE FINANCIAL RESULTS

Total operating income for the three months ended March 31, 2026, was $1.3 billion compared to $0.8 billion for the same period in 2025, and consists of:

Product net sales of VYVGART for the three months ended March 31, 2026, were $1.3 billion compared to $0.8 billion for the same period in 2025.
Other operating income for the three months ended March 31, 2026, was $15 million compared to $17 million for the same period in 2025. The other operating income primarily relates to research and development tax incentives and payroll tax rebates.
Total operating expenses for the three months ended March 31, 2026, were $0.9 billion compared to $0.7 billion for the same period in 2025, and mainly consists of:

Cost of sales for the three months ended March 31, 2026, was $121 million compared to $81 million for the same period in 2025. The cost of sales was recognized with respect to the sale of VYVGART.
Research and development expenses for the three months ended March 31, 2026, were $0.4 billion compared to $0.3 billion for the same period in 2025. The expenses mainly relate to:
Advancing efgartigimod across multiple severe autoimmune diseases;
Progressing empasiprubart into multiple indications;
Executing studies for adimanebart in rare neuromuscular diseases; and
Early-stage discovery and preclinical programs to sustain long-term pipeline growth.
Selling, general and administrative expenses for the three months ended March 31, 2026, were $0.4 billion compared to $0.3 billion for the same period in 2025. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to global commercialization of the VYVGART franchise, and personnel expenses.

Financial income for the three months ended March 31, 2026, was $44 million compared to $37 million for the same period in 2025.

Income tax expense for the three months ended March 31, 2026, was $60 million compared to $33 million for the same period in 2025. Income tax expense for the three months ended March 31, 2026, consists of $102 million of current income tax expense and $42 million of deferred tax benefit, compared to $29 million of current income tax expense and $4 million of deferred tax expense for the comparable prior period.

Profit for the period of three months ended March 31, 2026, was $366 million compared to $169 million in 2025, representing 116% growth year-over-year. The basic profit per share was $5.90 for the three months ended March 31, 2026, compared to $2.78 in 2025.

Cash, cash equivalents and current financial assets1 consisted of $4.3 billion in cash, cash equivalents and $0.6 billion in current financial assets which totaled $4.9 billion as of March 31, 2026, compared to $3.5 billion in cash and cash equivalents and $0.9 billion in current financial assets which totaled $4.4 billion as of December 31, 2025.

EXPECTED 2026 FINANCIAL CALENDAR

July 23, 2026: Half Year and Second Quarter 2026 Financial Results and Business Update
October 22, 2026: Third Quarter 2026 Financial Results and Business Update
CONFERENCE CALL DETAILS

The first quarter 2026 financial results and business update will be discussed during a conference call and webcast presentation today at 2:30 PM CET/8:30 AM ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.

(Press release, argenx, MAY 7, 2026, View Source [SID1234665213])